INX · Bed, Air Fluidized
Physical Medicine · 21 CFR 890.5160 · Class 2
Overview
| Product Code | INX |
|---|---|
| Device Name | Bed, Air Fluidized |
| Regulation | 21 CFR 890.5160 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972176 | HOME CARE BEAD BED | Kinetic Concepts, Inc. | Jan 16, 1998 | SESE |
| K964223 | CLINITRON RITE-HITE | Hill-Rom, Inc. | May 28, 1997 | SESE |
| K943385 | CLINITRON ELEXIS | Ssi Medical Services, Inc. | Feb 27, 1995 | SESE |
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY | Ssi Medical Services, Inc. | Feb 7, 1995 | SESE |
| K931168 | X-20 AIR SUPPORT BED | American Life Support Technology, Inc. | Feb 17, 1994 | SESE |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | Feb 2, 1994 | SESE |
| K924973 | DYLNAMEDICS A.S.A.P. | Dynamedics, Inc. | Oct 15, 1993 | SESE |
| K926402 | COMFORT CARE LOW AIR LOSS THERAPY BED | Ch Administration, Inc. | Mar 24, 1993 | SESE |
| K924686 | REM-AIR | Mellenair Ent., Inc. | Feb 12, 1993 | SESE |
| K920112 | CLINITRON C-II | Support Systems Intl. | Jan 24, 1992 | SESE |
| K913654 | SMITH AND DAVIS PRESSURE THERAPY SYSTEM | Smith & Davis Mfg. Co. | Nov 22, 1991 | SESE |
| K911246 | THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 | The Medical Group, Inc. | Jun 6, 1991 | SESE |
| K911057 | DERMATEK 4000 | Anacom General Corp. | Apr 5, 1991 | SESE |
| K904008 | STAGE IV, AIR-FLUIDIZE BED | Unique Flotation Systems, Inc. | Oct 10, 1990 | SESE |
| K890523 | SUPERCAIR | Ssi Medical Services, Inc. | Feb 10, 1989 | SESE |
| K884835 | TASSI MK2 | Therapy Air Support Systems, Inc. | Dec 7, 1988 | SESE |
| K884529 | MICROAIR FLUIDIZED AIR BED | Gsi Development Co. | Nov 18, 1988 | SESE |
| K881917 | FLUIDAIR | Kinetic Concepts, Inc. | Nov 14, 1988 | SESE |
| K881705 | MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM | Surgi-Med, Inc. | Jul 13, 1988 | SESE |
| K880340 | MODIFIED AIR FLUIDIZED BED, KINAIR | Kinetic Concepts, Inc. | Feb 16, 1988 | SESE |
Top Applicants
- Kinetic Concepts, Inc. — 3 clearances
- Ssi Medical Services, Inc. — 3 clearances
- Uhi Corp. — 2 clearances
- Air Plus, Inc. — 1 clearance
- American Life Support Technology, Inc. — 1 clearance
